MAUDE Adverse Event Report: SYNTHES GMBH SMALL BATTERY DRIVE; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

Catalog Number	532.010
Medical Device Problem Code	Complete Loss of Power (4015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.The actual device has been returned and is currently pending evaluation.Once the device has been evaluated, a supplemental medwatch report will be sent accordingly.Udi: (b)(4).
Event or Problem Description
It was reported that during an unspecified surgical procedure, it was observed that the small battery drive device was either smoking or would not run.The reporter was unsure about which one occurred.There were no reports of surgical delay.It was not reported if a spare device was available for use.There was patient involvement.There were no injuries, medical intervention or prolonged hospitalization.The date of event was unknown but was known to have occurred in (b)(6) 2020.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: the actual device was returned for evaluation.During repair, an evaluation was performed and it was determined that the device safety disk was missing, the unit would not run and components were missing.The device also failed pretests for check the off/oscillation/on switch mode function and check the function with electric pen drive console.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to component failure due to normal wear.

• Brand Name: SMALL BATTERY DRIVE
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10968664
• Report Number: 8030965-2020-09441
• Device Sequence Number: 17213943
• Product Code: HWE
• UDI-Device Identifier: 07611819110779
• UDI-Public: 07611819110779
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K971544
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 532.010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2020
• Supplement Date Received by Manufacturer: 01/11/2021
• Initial Report FDA Received Date: 12/08/2020
• Supplement Report FDA Received Date: 01/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1